Cognitive Control Targets for the Treatment of Obsessive Compulsive Disorder in Young Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorColumbia University
About this trial
This study aims to examine the effects of a game-like program called cognitive control training (CT) for children with obsessive compulsive disorder (OCD). Children enrolled in this study will receive 4 weeks of the at-home computerized cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games to engage cognitive control processes. Children will complete the NIH Toolbox prior to, mid (2-weeks), and post-CT (4-weeks). Participants will complete MRI scans pre- and post-CT and then be offered a 12-week course of gold-standard Cognitive behavioral therapy with exposure and response prevention (or community referrals) after CT. The long-term goal of this study is to test how this CT intervention may enhance cognitive control capacity to reduce symptoms and improve response to cognitive behavioral therapy with exposure and response prevention in children with OCD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages between 8 and 12 years;
Clinically significant OCD as the principal problem. This is defined as follows: they must meet DSM-V criteria for OCD as assessed with the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL). OCD must be the primary source of interference and distress (based on clinical evaluation with K- SADS-PL and Children's Yale-Brown Obsessive Compulsive Scale (C-YBOCS) and they must have clinically significant symptoms (i.e., C-YBOCS) ≥ 16;
Not on psychotropic medication (either treatment-naïve or free of psychotropic medication for at least three months) and not receiving current psychotherapy for OCD;
Ability to tolerate a treatment-free period (i.e., no treatment other than study CBT);
Disqualifiers
Current or past diagnosis of major depressive disorder, PTSD, substance/alcohol abuse, psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, substance/alcohol dependence, or any other Axis I disorder not listed above;
Active suicidal ideation;
Females who are pregnant or nursing;
Any major medical or neurological problem (e.g., unstable hypertension, seizure disorder, head trauma); -Positive urine screen for illicit drugs;
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive Control Training (CT)
Device4 weeks of an at-home computerized cognitive training program (AKL-T01) delivered on iPad (25 minutes/day, 5 days/week). Styled as a child-friendly video game, AKL-T01 CT taps focused attention, response inhibition, and working memory using a series of games with individually titrated difficulty to engage cognitive control processes.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Cognitive Training for Obsessive-Compulsive DisorderExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
NIH Toolbox Cognition Battery
Standardized Cognitive Function Composite Scores will be derived from the following NIH Toolbox tasks: 1) Flanker inhibitory control and attention task, 2) Dimensional Change Card Sort (DCCS) test of set-shifting function, 3) List of Working Memory Test, and 4) Pattern Comparison Processing Speed Test.
Time frame
Baseline, 2-week follow-up (mid-training), and 4-week follow-up (post-training)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov